FDA Law Blog

JUNE 14, 2021

This step would help propel forward a public conversation (which CMS has already started ) about how to update these regulations in light of technological advances. FDA argues that technological advances in LDTs necessitate FDA’s regulatory oversight pursuant to the Food, Drug, and Cosmetic Act (FDCA).

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Technology Manufacturing Statute Laws 92

SCOTUSBlog

DECEMBER 10, 2022

The move came in response to a tide of lawsuits brought against manufacturers of the technology by women who alleged serious complications from its use in surgery. California allows consumers, or state regulators on behalf of consumers, to sue businesses for failing to warn of a product’s risks. United States v.

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Manufacturing Statute Attorney Court 77

Patently O

FEBRUARY 24, 2022

Eligibility under Section 101 : American Axle & Manufacturing, Inc. 20-891 (CVSG requested May 3, 2021); Res Judicata and the Patent-Specific Kessler Doctrine : PersonalWeb Technologies, LLC v. The statute indicates that any party to an IPR final-written-decision has a right to appeal. VLSI Technology LLC.

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Patently O

APRIL 15, 2021

An inferior officer decision will interpret the statute as providing the PTO director with substantial authority; a principal officer decision will downplay the role of the PTO director. Kingston Technology Company, Inc., 20-92; Vilox Technologies, LLC v. 20-408; Micron Technology, Inc. Luoma, et al. , Iancu , No.

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Laws Court Technology Construction 83

Patently O

NOVEMBER 21, 2023

In it, the USPTO reaffirmed its prior interpretation of the phrase “design for an article of manufacture” and did not—as many had hoped—expand its interpretation of that phrase. In late December 2020, the USPTO published a request for information on “The Article of Manufacture Requirement.” 11380, 11381 (footnotes omitted).

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Manufacturing Technology Law School Statute 59

FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Please refer to the help text in this section for the content that is required according to this statute.”

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Laws Manufacturing Drafting Technology 105

The Process Street

NOVEMBER 28, 2023

And, while we can’t perfectly predict the emergence of a Skynet singularity, we can say with some certainty that technology is set to take over the repetitive, dehumanizing elements of our jobs instead of putting us out of work. Source ) A decade ago, the technology was hardly mature enough to be of any practical use.

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The Fashion Law

FEBRUARY 10, 2022

Moreover, Rothschild’s sale of each digital artwork with an NFT, “the technological means by which Rothschild authenticates his artworks, makes no difference: Rothschild’s First Amendment rights do not depend on how he sells his art any more than they depend on whether he sells it.”).

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Manufacturing Statute Legal Legal 119

Patently O

MAY 8, 2024

Zircon is the latest in a series of appellate decisions focusing on the nuance of domestic industry, especially in our era where so many products are manufactured abroad. The court noted that the domestic industry statute, 19 U.S.C. That interpretation, however appears precluded by the statute. ” 19 U.S.C. 1337(a)(2).

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Statute Manufacturing Court Technology 59

Patently O

MARCH 18, 2024

The key technology relates to the container’s “port boss” – essentially a nozzle comprising inner (male) and outer (female) components that are compressed together to sandwich and seal against the liner of the vessel holding the gas. The inventorship correction statute – 35 U.S.C. §

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Statute Cause of Action Court Rules Litigating 59

Conflict of Laws

NOVEMBER 23, 2023

Apart from customary international law, it is also doubtful that Meng’s conduct in Hong Kong fell within the scope of the federal bank and wire fraud statutes. conduct is required under the federal bank and wire fraud statutes, Meng engaged in no U.S. The machines to make these chips are manufactured in the Netherlands.

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Manufacturing Technology Statute Laws 64

Patently O

APRIL 27, 2022

In December 2020, the USPTO put out a request for comments on “The Article of Manufacture Requirement.” (For Presumably, this acronym is meant to suggest that these are new types of designs, uncontemplated by Congress when it passed statutes that—according to some—are in need of “modernization.”. For prior PatentlyO coverage, see here.)

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Manufacturing Statute Technology Laws 69

FDA Law Blog

APRIL 19, 2021

Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. As most readers of our blog are aware, the regulatory costs to manufacturers of medical products are much lower if FDA regulates a product as a medical device rather than a drug requiring FDA marketing approval.

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Court Manufacturing Statute Technology 40

Patently O

NOVEMBER 21, 2021

Mennell, Koret Professor of Law; Director, Berkeley Center for Law & Technology; Faculty Director, Berkeley Judicial Institute; University of California at Berkeley School of Law, and Ella Corren, University of California at Berkeley School of Law, J.S.D. Guest post by Peter S.

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Manufacturing Statute Laws Technology 75

Patently O

MARCH 27, 2024

A forceful dissent by Judge Lourie argues that the majority’s approach, while following precedent, improperly reads the word “solely” out of the statute and unduly expands the safe harbor exemption. Edwards holds several patents covering artificial heart valve technology. . § 271(e)(1). 35 U.S.C. § 271(e)(1).

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Statute Manufacturing Court Technology 45

Patently O

JUNE 12, 2024

Although the Federal Circuit had previously held that the claimed invention was “technological,” the court here concluded that it was not bound by that prior non-precedential decision. ” See, Burke, Inc.

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Litigating Litigation Statute Court 53

At the Lectern

DECEMBER 19, 2024

The Second District, Division Six, published opinion , held that the car manufacturer in the case “is not a third party beneficiary of the sale contract and petitioners are not estopped from objecting to arbitration.” Uber Technologies, Inc. Section 11362.3 ” Another f orum selection grant-and-hold. In People v.

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Manufacturing Contract Court Statute 45

Patently O

JANUARY 22, 2024

Back to terminal disclaimers : The statute appears relatively clear that patent-term-adjustment does not extend a patent term beyond that disclaimed in a terminal disclaimer. Love – Gibson, Dunn & Crutcher LLP Language Technologies, Inc. Andre – Kramer Levin Naftalis & Frankel LLP Samsung Electronics Co.,

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Manufacturing Drafting Statute Technology 49

Conflict of Laws

SEPTEMBER 15, 2024

For instance, in a case involving a request for evidence from French airplane manufacturing companies by victims of an airplane crash, instead of a first resort to the Hague Evidence Convention, the U.S. Several lecturers referred to the use of AI technologies in dispute resolution, including AI courts.

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Laws Contract Court Litigating 59

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. Furthermore, even if the Third-Party Review Program could gain traction within the IVD industry, it is, per statute, available only to select Class I and II devices. [15]

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Manufacturing Statute Technology 69

Patently O

SEPTEMBER 26, 2022

The most anticipated case last year was the 101 eligibility petition regarding automobile drive shaft manufacturing process. One way to think about this case is the level of responsibility that the generic manufacturer has to make sure that its drug is not used in an infringing way. American Axle (cert denied). Apple Inc. ,

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Court Laws Manufacturing Statute 126

Customs & International Trade Law

SEPTEMBER 30, 2023

The rule elaborates on two core provisions of the statute: Prohibiting CHIPS funds recipients from expanding material semiconductor manufacturing capacity in foreign countries of concern for ten years; Restricting recipients from certain joint research or technology licensing efforts with foreign entities of concern.

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Government Small Business Diligence Technology 104

Patently O

DECEMBER 22, 2022

USPTO written description rejections most often occur based upon late-stage claim amendments, and those can happen in any area of technology. In my view, the generic manufacturer here has a very strong estoppel defense because the patentee itself proposed the language used on the generic label. California Institute of Technology , No.

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Court Laws Manufacturing Technology 60

Intelligize Blog

JULY 11, 2023

An alternative explanation for the trends may be that in previous years, companies ramped up DEI efforts to comply with Nasdaq’s board diversity disclosure rules and the various California board diversity statutes, so it was inevitable that growth would level off. Similarly, some criticisms of the decision have focused on keeping U.S.

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Manufacturing Statute Technology Court 54

Patently O

JULY 6, 2022

He was doing some amateurs woodworking when he conceived of his SawStop technology. And, in any case, these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years. In the area of obviousness though, the doctrine was developed by courts and then implemented by statute in 1952.

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Stare Decisis Statute Court Construction 75

Customs & International Trade Law

MAY 13, 2022

On May 9, 2022, the FDA issued a Constituent Update stating that Glanbia Performance Nutrition (Manufacturing), Inc. The complaint, as supplemented, further alleges that an industry in the United States exists as required by the applicable Federal Statute. Here is a recap of the latest customs and international trade law news: FDA.

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Laws Manufacturing Administrative Law Government 97

SCOTUSBlog

NOVEMBER 29, 2024

In 2016, the FDA issued a rule classifying e-cigarette products as “new tobacco products,” which required the manufacturers of those products to apply for approval to continue to sell them. That prompted Triton Distribution and Vapetasia to apply to the FDA for authorization to market flavored liquids for use in e-cigarettes.

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Court Manufacturing Statute Technology 126

Foley Hoag LLP

APRIL 5, 2023

While the Act is heavily focused on the Uyghur peoples in the Xinjiang region, it is important to bear in mind that the statute is ultimately aimed at forced labor inputs from all religious and ethnic minority groups throughout China. market deemed to have been made with forced labor regardless of where such abuses originated.

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Diligence Statute Manufacturing Legal 40

ClimateChange-ClimateLaw

OCTOBER 20, 2020

1442, or the civil-rights removal statute, 28 U.S.C. The district court rejected eight grounds for removal, but the Fourth Circuit concluded its appellate jurisdiction was limited to determining whether the companies properly removed the case under the federal-officer removal statute. Truck Trailer Manufacturers Association, Inc.

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Court Government Compensatory Damages Litigation 72

Customs & International Trade Law

DECEMBER 27, 2024

Publications & Articles Clock Ticking: Potential Government Shutdown on the Horizon , December 2024 CPSC Approves Final Rule to Implement eFiling for Certificates of Compliance , December 2024 Trade News: New AD/CVD Case Filed on Active Anode Material from China , December 2024 Trade News: New AD/CVD Case Filed on Erythritol from China , December (..)

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eFiling Laws Small Business Manufacturing 40

Patently O

DECEMBER 14, 2021

Eligibility : American Axle & Manufacturing, Inc. The Federal Circuit concluded that American Axle’s vehicle-manufacturing claims are ineligible under the two-part tests of Alice and Mayo. The claims here are directed to a method of manufacturing an automobile drive-shaft with reduced vibration. Janssen and Apple v.

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Laws Court Manufacturing Technology 86

SCOTUSBlog

JANUARY 26, 2022

That interpretation, Kruger reasoned, is more consistent with both the text of the statute and the California legislature’s intent in enacting the law. The National Shooting Sports Foundation, a trade association for gun manufacturers, argued that the requirement should be invalidated because it was impossible to implement the technology.

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ClimateChange-ClimateLaw

OCTOBER 19, 2023

The challenge of meeting changing conditions in administrative law is known as the pacing problem: scientific and technological developments will nearly always outstrip the pace of government oversight. However, it objected to the EPA’s interpretation of its authorizing statute.

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Statute Court Government Administrative Law 85

JonathanTurley

NOVEMBER 27, 2020

The litigation over last year’s lettuce recall has only just started due to the statute of limitations. The cases from injuries last year are just now being filed under the statute of limitations, but it has been another bumper crop of Thanksgiving torts. Macy’s Parade also did not disappoint with its balloon-related mishaps.

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ClimateChange-ClimateLaw

MARCH 13, 2023

In 2022, Texas, along with several other states and industry groups representing fuel manufacturers (together, Petitioners), challenged EPA’s new emissions standards in court. These standards required each automobile manufacturer to reduce the average emissions from its vehicle fleet by approximately 5% per year between 2012 and 2025.

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Manufacturing Government Court Administrative Law 59

Above The Law

MARCH 7, 2025

Jackson also inquired about the potential impact of a ruling on the statute of limitations and how courts should approach medical expertise when evaluating agency decisions, especially regarding the safety and efficacy of drugs. Her inquiries aim to clarify the laws structure, urging a closer examination of its effects on different groups.

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Constitutional Law Laws Statute Legal 103

Foley Hoag LLP

JULY 20, 2020

In addition to the camps, the Chinese Government has used technologies that include facial recognition, genetic testing, and big data, as well as employing conventional methods such as community informants, to surveil and gather information on Uyghurs. Most of the companies on the list are in the processed food and apparel industries.

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Diligence Government Malfeasance Laws 40